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Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

NCT ID: NCT05659433

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-11-30

Brief Summary

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Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).

Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.

Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.

Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.

The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.

Detailed Description

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Conditions

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Retroperitoneal Neoplasms

Keywords

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Percutaneous biopsy Contrast-enhanced ultrasonography CEUS Retroperitoneal neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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B-mode Ultrasound-guided Biopsy

Group Type ACTIVE_COMPARATOR

B-mode US-guided percutaneous biopsy

Intervention Type PROCEDURE

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

Contrast-enhanced Ultrasound-guided Biopsy

Group Type EXPERIMENTAL

CEUS-guided percutaneous biopsy

Intervention Type PROCEDURE

A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)

Interventions

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CEUS-guided percutaneous biopsy

A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)

Intervention Type PROCEDURE

B-mode US-guided percutaneous biopsy

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with retroperitoneal tumors with indication for percutaneous biopsy

Exclusion Criteria

* Tumors inaccessible for ultrasound guided biopsy
* Standard contraindications for biopsy (altered coagulation tests, poor performance status)
* Lack of written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

OTHER

Sponsor Role collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Rareș Crăciun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeno Spârchez, MD, Prof.

Role: STUDY_CHAIR

Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca

Locations

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Prof. Dr. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania

Site Status

Countries

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Romania

Other Identifiers

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CEUS-PBRT

Identifier Type: -

Identifier Source: org_study_id